Application 022030

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOVIAZ	FESOTERODINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	4MG	Yes	No
002	TOVIAZ	FESOTERODINE FUMARATE	TABLET, EXTENDED RELEASE;ORAL	8MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022030-001	TOVIAZ	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31
N022030-002	TOVIAZ	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022030-001	AB
N022030-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022030-001	7807715	2027-06-07	U-913	Drug product
N022030-001	8088398	2027-06-07	U-913	Drug product
N022030-001	8501723	2027-06-07		Drug product	2013-08-20
N022030-001	7807715*PED	2027-12-07		Pediatric extension
N022030-001	8088398*PED	2027-12-07		Pediatric extension
N022030-001	8501723*PED	2027-12-07		Pediatric extension
N022030-002	7807715	2027-06-07	U-913	Drug product
N022030-002	8088398	2027-06-07	U-913	Drug product
N022030-002	8501723	2027-06-07		Drug product	2013-08-20
N022030-002	7807715*PED	2027-12-07		Pediatric extension
N022030-002	8088398*PED	2027-12-07		Pediatric extension
N022030-002	8501723*PED	2027-12-07		Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022030-001	TOVIAZ	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022030-002	TOVIAZ	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-10-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022030-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022030-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022030-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022030-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022030-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022030-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022030-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022030-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022030-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022030-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022030-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022030-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022030-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022030-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022030-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022030-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022030-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022030-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022030-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022030-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 556 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022030-001	7807715	2027-06-07	U-913	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-001	8088398	2027-06-07	U-913	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-001	8501723	2027-06-07		Drug product	2013-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-001	7807715*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-001	8088398*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-001	8501723*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	7807715	2027-06-07	U-913	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	8088398	2027-06-07	U-913	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	8501723	2027-06-07		Drug product	2013-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	7807715*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	8088398*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022030-002	8501723*PED	2027-12-07		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022030-001	7807715	2027-06-07	U-913	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-001	8088398	2027-06-07	U-913	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-001	8501723	2027-06-07		Drug product	2013-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-001	7807715*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-001	8088398*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-001	8501723*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	7807715	2027-06-07	U-913	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	8088398	2027-06-07	U-913	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	8501723	2027-06-07		Drug product	2013-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	7807715*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	8088398*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022030-002	8501723*PED	2027-12-07		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	7807715	2027-06-07	U-913	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	8088398	2027-06-07	U-913	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	8501723	2027-06-07		Drug product	2013-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	7807715*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	8088398*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-001	8501723*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	7807715	2027-06-07	U-913	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	8088398	2027-06-07	U-913	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	8501723	2027-06-07		Drug product	2013-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	7807715*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	8088398*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022030-002	8501723*PED	2027-12-07		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022030-001	7807715	2027-06-07	U-913	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022030-001	8088398	2027-06-07	U-913	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022030-001	8501723	2027-06-07		Drug product	2013-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022030-001	7807715*PED	2027-12-07		Pediatric extension		`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-001	I-861	2024-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-001	PED	2024-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-002	I-861	2024-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022030-002	PED	2024-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-001	I-861	2024-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-001	PED	2024-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-002	I-861	2024-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022030-002	PED	2024-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-001	I-861	2024-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-001	PED	2024-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-002	I-861	2024-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022030-002	PED	2024-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-001	I-861	2024-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-001	PED	2024-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-002	I-861	2024-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022030-002	PED	2024-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022030-001	I-861	2024-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022030-001	PED	2024-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022030-002	I-861	2024-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022030-002	PED	2024-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-001	I-861	2024-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-001	PED	2024-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-002	I-861	2024-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022030-002	PED	2024-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-001	I-861	2024-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-001	PED	2024-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-002	I-861	2024-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022030-002	PED	2024-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-001	I-861	2024-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-001	PED	2024-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-002	I-861	2024-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022030-002	PED	2024-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022030-001	I-861	2024-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022030-001	PED	2024-12-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022030-002	I-861	2024-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022030-002	PED	2024-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-001	I-861	2024-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-001	PED	2024-12-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-002	I-861	2024-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022030-002	PED	2024-12-17	`5c6f7cd8ea54…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Toviaz	FESOTERODINE FUMARATE	Pfizer Laboratories Div Pfizer Inc	5be745f0-8ae7-4c3c-9962-37d6263326f1	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022030 application number: NDA022030 ndc (product): 0069-0244 ndc (product): 0069-0242

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0242	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0242	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0242	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0242	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0242	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0242	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0242	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0242	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0244	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0244	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0244	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0244	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0244	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0244	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0244	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0244	Toviaz	fesoterodine fumarate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
55154-2737	Toviaz	fesoterodine fumarate	Cardinal Health	NDA	Current
55154-2737	Toviaz	fesoterodine fumarate	Cardinal Health	NDA	Current
55154-2737	Toviaz	fesoterodine fumarate	Cardinal Health	NDA	Current
55154-2738	Toviaz	fesoterodine fumarate	Cardinal Health	NDA	Current
55154-2738	Toviaz	fesoterodine fumarate	Cardinal Health	NDA	Current
55154-2738	Toviaz	fesoterodine fumarate	Cardinal Health	NDA	Current
63539-183	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-183	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-183	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-183	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-183	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-183	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-183	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-183	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-242	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-242	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-242	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-242	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-242	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-242	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-242	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
63539-242	Toviaz	fesoterodine fumarate	U.S. Pharmaceuticals	NDA	Current
69189-0242	Toviaz	fesoterodine fumarate	Avera McKennan Hospital	NDA	Current
69189-0244	Toviaz	fesoterodine fumarate	Avera McKennan Hospital	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77676	SUPPL	2024-02-29
77675	SUPPL	2024-02-29
77661	SUPPL	2024-02-29
77660	SUPPL	2024-02-29
67876	SUPPL	2021-06-23
67854	SUPPL	2021-06-22
50428	SUPPL	2017-11-15
50361	SUPPL	2017-11-13
6726	SUPPL	2012-08-03
16801	SUPPL	2012-08-02
38109	SUPPL	2012-01-06
29108	SUPPL	2012-01-03
16799	SUPPL	2011-11-18
29107	SUPPL	2011-11-03
6725	SUPPL	2011-02-14
16800	SUPPL	2011-02-11
6724	SUPPL	2010-04-08
38108	SUPPL	2010-04-04
44668	ORIG	2009-02-26
42395	ORIG	2009-02-26
29106	ORIG	2008-11-07
16798	ORIG	2008-11-07